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Abstract Details

Edaravone for Amyotrophic Lateral Sclerosis: Oral Formulation and Its Development Plan
Neuromuscular and Clinical Neurophysiology (EMG)
P8 - Poster Session 8 (8:00 AM-9:00 AM)
1-001
To describe progress in the clinical development plan for an oral formulation of edaravone.
An intravenous (IV) formulation of edaravone is approved for use in amyotrophic lateral sclerosis (ALS) in Japan, South Korea, the United States, Canada, Switzerland, and China. For possible ease of administration, an oral suspension formulation of edaravone is being developed to address unmet patient needs.
A Phase 1, dose-ranging PK study was conducted in healthy volunteers. A PK bridging study was also completed. This will be followed by Phase 3 studies in patients with ALS.

A single oral dose of approximately 100 mg of edaravone appeared to deliver Cmax and AUC exposure comparable to that of the approved 60 mg/60 min IV infusion. No significant safety findings were observed following single doses of up to 300 mg of oral edaravone.

The clinical development plan for the oral suspension is ongoing. A PK bridging strategy is completed, including a study confirming similar PK profiles between the oral and IV formulations. The safety and tolerability of oral edaravone in dosing cycles the same as the approved IV formulation will be assessed in a 48-week, multi-center, open-label, Phase 3 study in 150 adult patients with ALS. In addition, as part of a US postmarketing commitment, the efficacy and safety of daily dosing of oral edaravone will be compared to that in the dosing cycles in a double-blind, Phase 3b global study in patients with ALS. The latest study design will be presented at the conference.
PK data indicated that an oral formulation of edaravone produces a profile similar to that of the current IV formulation. It is hoped that the clinical development plan with PK bridging and safety and tolerability of the oral formulation will provide the data needed to seek appropriate marketing authorizations.
Authors/Disclosures
Koji Takei (Mitsubishi Tanabe Pharma Corporation)
PRESENTER 		No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Makoto Akimoto No disclosure on file
No disclosure on file